Suzanne Elder’s Post

There is no rhyme or reason that racial, ethnic, sex, gender, age, etc make up of patient populations shouldn't be reflected in clinical trials that test drugs, devices, procedures in those patients, but that is our history. We've done so poorly at ensuring trials represent real world patient populations that so many times we don't know if a drug would be effective in a female or in a child, for example. DEI in clinical trial design ensures that we can have confidence in the results of the trial because the intervention was tested on adequately representative patients.

📢 MRCT Center Public Comment Submission The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) recently submitted public comments to the FDA on its draft guidance for Diversity Action Plans (#DAPs), highlighting key areas where transparency and clarity are needed. Our comments emphasize the importance of clear FDA feedback timelines and assessment criteria for community engagement, site selection, recruitment, enrollment, and retention plans, both domestically and globally. We also recommend: Clarifying DAP requirements for Phase 3 trials (new and previously approved products), Implementing a “do no harm” approach for global participants, Considering when to disaggregate US and global enrollment goals/data. To improve the guidance, we suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations toward effective diversity strategies. ➡️ Click here to read the public comments: https://bit.ly/4eteYIP #ClinicalTrials #DiversityInResearch #GlobalTrials #InclusiveResearch #CommunityEngagement #DAP #InclusionInScience

Diversity in clinical trials isn't just a moral imperative—it's a scientific one. The removal, under direction of the current administrations mandate to halt all HHS external communications, of the FDA's recent draft guidance emphasizing the importance of Diversity Action Plans to ensure trial results accurately reflect the populations that will use the investigational drugs in the real world, is scientifically irresponsible and re-introduces distrust in our healthcare system. These plans help sponsors proactively identify and address barriers to enrollment for underrepresented groups, such as racial and ethnic minorities, women, and older adults. By doing so, we can better understand how investigational agents perform across diverse populations, paving the way for safer and more effective treatments for everyone. Inclusion isn't optional—it's essential for equity and innovation in healthcare. Let’s continue to build trials that reflect the world we serve. #ClinicalTrials #DiversityInResearch #HealthEquity #FDA

🌍 Advancing Diversity in Clinical Trials: A Shared Mission 🌍 During the recent Clinical Trial Forum & New Year’s Reception pharma.be I had the privilege of meeting the inspiring Susan Tio, Ph.D. Senior Director and EU Region Lead for Diversity & Inclusion in Clinical Trials at Sanofi. Her vision for fostering diversity in clinical trials left a profound impression on me, especially her closing quote: "When 'I' is replaced by ‘We' even ‘illness’ becomes ‘Wellness.’" – Malcolm X This simple yet profound statement reminds us that collaboration is the foundation of progress. It challenges us to see diversity not just as a checkbox but as a bridge to true equity where everyone, everywhere, has the chance to experience the best that medicine can offer. Representation is not just a moral imperative it’s a scientific necessity. When trials truly reflect the diversity of the populations we aim to serve we create more accurate, equitable and impactful health solutions. Why is this important following you ? Diverse and Inclusive clinical trials improve the reliability of research outcomes, ensure medicines are effective for all populations and build trust within underrepresented communities. It's a step toward addressing long-standing health disparities and creating a more inclusive future for global healthcare. Meeting leaders like Susan Tio, Ph.D. reinforce the value of collaboration across the industry. Together, we can work toward a shared vision where diversity is embedded in every phase of clinical development. At Pfizer DEICE, I am proud to contribute to this journey as we strive to embed diversity in clinical trials . My reflection for you today is this : What role will you play in turning illness into wellness for everyone, everywhere? Let’s come together, sharing ideas, stories of success and best practices to make inclusive clinical trials the standard not the exception. Because when diversity thrives, health equity follows and together we create a world where no one is left behind. #DiversityInClinicalTrials #EquityInHealthCare #InclusiveLeadership #DEICE #RepresentationMatters #pfcolleague

✨ Advancing Inclusivity in Clinical Research ✨ The FDA's guidance encouraging Diversity Action Plans for clinical trials is a meaningful step forward for the field of healthcare innovation. By aiming to ensure that trial participants reflect the diversity of patients who will ultimately benefit from these treatments, this initiative highlights the importance of making research as inclusive and representative as possible. (Learn more) https://lnkd.in/gaSNx-ij As someone who has worked closely with patients from diverse backgrounds, I’ve seen how inclusive approaches in research and care can lead to better outcomes. Ensuring diverse representation in trials isn’t just about addressing disparities—it’s about creating a healthcare system that works effectively for everyone. This is a thoughtful reminder of the progress we’re making in clinical research and the opportunities we have to continue improving. 💡 I’d love to hear your thoughts on this development and the importance of diversity in research! #ClinicalResearch #DiversityInScience #HealthcareInnovation #PublicHealth #ClinicalTrials

Walgreens and BARDA have joined forces to help implement a new paradigm of decentralized clinical trials. This strategic partnership aims to enhance U.S. clinical research capabilities and support life sciences product development. The end goal is to ultimately boost clinical research innovation and more efficiently recruit and fill studies with patients who can benefit from cutting edge medicines. Walgreens' current clinical trial ecosystem has already reached over 5 million potential participants and this partnership will leverage Walgreens' extensive network of community pharmacies. Additionally, this should improve accessibility and representation in clinical trials. Nearly 80% of trials fail to meet enrollment goals on time. This initiative could significantly reduce delays and costs in medical research, a true win-win. https://lnkd.in/gpqRSK6Y

Championing Diversity in Clinical Trials: A Crucial Step Forward The recent FDA guidance on Diversity Action Plans is a pivotal moment in our mission to ensure that drug and device development truly reflects the diverse needs of all patients. Embracing patient diversity is not just a regulatory requirement—it’s a fundamental aspect of delivering equitable healthcare. Did you know that historically, certain patient groups have been significantly underrepresented in clinical trials? For example, African Americans represent only 5% of clinical trial participants, while Hispanic/Latino populations account for just 1%. Are you ready to integrate these essential plans into your clinical trials? Together, we can enhance the inclusivity and representativeness of our studies, ultimately leading to better health outcomes for every patient. Let’s spread the word and make a difference! Share this message with your network and join me in championing diversity in clinical trials. #DiversityInClinicalTrials #ClinicalResearch #Diversity #Equity #Healthcare https://lnkd.in/gXy_iAuv

It never gets old! (even though I apparently do) ⌛ It's been a little while since I was helping guide a global pharma company and the broader pharma industry to establish and integrate regular patient engagement into medicines development and research... 🧨 ...But it took nothing at all for it all to come back to me when getting the chance to speak with this amazingly inspirational group of patients and family members from the Huntington's Disease community! We are prepping for a Patient Focused Drug Development Meeting with the FDA in November. I am honored to be their trusted Moderator for this special engagement convening a couple hundred patients, family members, researchers, medical product developers and FDA staff and experts. These panelists have prepared not only heartfelt ❤️🔥 and insightful stories 💡, but they also have clear messages of accountability 🎯 and specific calls to action 🚨. Patient engagement at its best! 🥇 They are so ready!! 👏 And I can't wait! 🤩 (oh... and for the funny ending to this post and this week...was on a call yesterday when someone said "well, I'm a good bit younger than you but I also..." 🤣 . I know what they meant, no worries but it WAS funny - especially since they didn't notice. 😂 ) [Updated prior post with edited image to remove names. I appreciate Amanda Brennan , for mentioning it to me. Even though patients had allowed for their names to be used on public meeting materials, her question helped me see I could better model best practice for privacy, so I am. And since LI ridiculously doesn’t enable editing images in a post, I’ve had to do a new one. But for a worthwhile reason. And I’ll add a hashtag of #sharedaccountability. 💙 It’s great to have great people in your village!] #patientengagement #huntingtonsdisease #PFDD #moderators

Patient advocacy is critical in this era of personalized medicine and risk based compliance. Establishing communication channel with regulatory authorities is important not just for drug companies, but also for patients! If you know anybody who is impacted by Huntington's, please connect with Elizabeth Manning and help pioneer treatment. #Advocacy #Huntingtons #FDA

The FDA has released a new draft guidance called "Diversity Action Plans for Enhancing Enrollment of Underrepresented Groups in Clinical Trials." According to FDA Commissioner Robert M. Califf, M.D., it is essential for clinical trial participants to mirror the patients who will ultimately benefit from the medical products. By implementing Diversity Action Plans, clinical trials can become more inclusive and better represent the diverse populations they aim to serve. EmVenio is excited to be part of this effort to connect with underrepresented communities and ensure equal access to clinical trials for all. https://hubs.ly/Q02DCHYz0 Contact us today to include EmVenio in your Diversity Action Plan -> https://hubs.ly/Q02DCHgy0 #FDA #Diversityactionplan #clinicaltrials #representation #EmVenioImpact